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Therapeutic Areas for Wearable Devices in Clinical Trials

Statistical Consultancy Team

Wearable devices are currently growing hugely in popularity, with predictions that the market will grow to $25 billion by 20191. Many of these devices, like the FitBit or Jawbone, are fairly cheap and affordable to the public. With the rising prevalence of chronic conditions like obesity due to our increasingly sedentary lifestyles, the use of wearable technology is on the up. Although initially marketed to consumers wanting to track their health and fitness, many wearable medical devices are now being designed and their potential use in clinical trials could completely transform and revolutionise the pharmaceutical industry. The obvious benefits to incorporating wearables in clinical trials are a higher compliance rate and reduced dropout rate, because wearing a device to monitor various vital signs and endpoints can reduce the need for hospital visits. For the same reason, clinical trials could have a much higher uptake and recruitment rate. The large amount of additional data could mean a lower variability, so fewer subjects could be needed to achieve statistical power.  However, this concept is virtually brand new and has major questions that need to be answered before real progress in this area can begin.

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Topics: Therapeutic Areas, Wearables in Clinical Trials, Wearables

Should We Be Integrating Mobile Health Apps in Clinical Trials?

Statistical Consultancy Team

Wearables and mobile health (Mhealth) apps collect subject/patient data from mobile or purpose built devices to record data in real time. The rationale behind this type of technology is to reduce the burden on subjects by eliminating unnecessary procedures, streamlining routine procedures and reducing time spent at clinical trial sites. It is evident from the review of a range of literature that studies integrating some form of mobile health technology can be broadly categorised into a few phases of development: studies on the development of new devices, studies on the validity of functional wearable devices, studies comparing new device and conventional endpoints, and finally those studies which trial the device as a health intervention. This article aims to briefly discuss these phases with reference to examples of recent studies demonstrating some safety or efficacy endpoint relating to a newly developed device.

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Topics: Clinical Trials, Clinical Study Design, Biostatistics Consulting, Technology Trends, Wearables in Clinical Trials, Wearables, mHealth

mHealth Apps and Wearables in Clinical Trials to Consider

Nick Burch

Today, mHealth, Mobile Health, Mobile Apps and Wearables are hot topics with consumers and regulators alike. We're also starting to see consumer-grade wearables and mHealth technologies creeping into clinical trials. We've written this blog for those looking to use this area more.

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Topics: Regulatory Requirements, FDA, European Medicines Agency, Quality Assurance, Mobile Device, Technology Trends, Wearables in Clinical Trials, Wearables, mHealth

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